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Influence of SRP With MM on the Composition and Functional Characteristics of Subgingival Microbiome Communities

NCT05422742 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-07-22

No results posted yet for this study

Summary

The purpose of this study is to characterize the effect of minocycline microspheres (MM) administered as an adjunct to scaling and rooting planning (SRP) on the subgingival community composition and metatranscriptome functional profile, in comparison to a group treated with SRP only and to periodontally-healthy subjects.

Conditions

  • Periodontitis

Interventions

PROCEDURE

SRP + MM

Subjects will be randomized into either SRP only or SRP +MM. Periodontal therapy will consist of one visit full-month SRP alone or in-combination with MM placed at all sites regardless of probing pocket depth. Each site will recieve 1mg of MM for a total of 6mg of MM per tooth.

PROCEDURE

Scaling and Root Planing (SRP)

Procedure involving removal of dental plaque and calculus (scaling or debridement) and then smoothing, or planing, of the (exposed) surfaces of the roots, removing cementum or dentine that is impregnated with calculus, toxins, or microorganisms, the etiologic agents that cause inflammation.

Sponsors & Collaborators

  • Bausch Health Americas, Inc.

    collaborator INDUSTRY

  • West Virginia University

    lead OTHER

Principal Investigators

  • Arif Salman, DDS · West Virginia University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-10-15
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05422742 on ClinicalTrials.gov